RESUMEN
OBJECTIVE: The purpose of this investigation was to evaluate the gastrointestinal (GI) tolerability profile of diclofenac epolamine topical patch 1.3% (DETP) during short-term treatment in patients with mild-to-moderate pain. DESIGN: Fourteen clinical trials of DETP were examined; 10 placebo-controlled studies were further integrated for analyses. All adverse event (AE) data were coded to the Medical Dictionary for Regulatory Activities. OUTCOME MEASURES: Frequency of GI AEs was summarized by treatment, preferred term, sex, and age group. RESULTS: The percentage of patients reporting GI AEs were similar between patients treated with the DETP and placebo, with only 3 of the 10 placebo-controlled trials reporting events in >2% of patients; there was no significant difference between DETP and placebo for any preferred GI term. The most common GI AE reported for both treatment groups was nausea (1.5% DETP, 1.1% placebo). There was no significant difference between treatment groups and sex in the number of reported events and no noted difference between age groups. CONCLUSION: This study provides evidence that DETP is a topical nonsteroidal anti-inflammatory drug that is a well-tolerated treatment option, demonstrating a low incidence of GI AEs across 14 clinical trials, making it a possible alternative to short-term oral NSAIDs, which are commonly associated with GI complications.
Asunto(s)
Antiinflamatorios no Esteroideos/efectos adversos , Diclofenaco/análogos & derivados , Tracto Gastrointestinal/efectos de los fármacos , Adulto , Factores de Edad , Anciano , Antiinflamatorios no Esteroideos/administración & dosificación , Diclofenaco/administración & dosificación , Diclofenaco/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dolor/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores Sexuales , Parche TransdérmicoRESUMEN
Topical nonsteroidal anti-inflammatory drugs (NSAIDs) have an emerging role in the treatment of certain types of acute pain. In addition to their convenience, efficacy, and safety, they are an attractive option, particularly when considering current concerns about the safety of traditional NSAIDs and cyclooxygenase-2 (COX-2) inhibitors (coxibs). Topical analgesics act largely within the peripheral nervous system. Studies have demonstrated that topical NSAIDs penetrate the skin and distribute to the target tissues underlying the application site. Because the pharmacologically effective dose is delivered at the site of pain, there is minimal systemic absorption and risk of related adverse events. Topical NSAIDs have been used for many years in Europe, with extensive post-marketing data available for some of the agents. Three topical NSAID formulations have recently been approved for use in the United States: the diclofenac epolamine topical patch 1.3% (DETP), diclofenac sodium 1% gel, and diclofenac sodium topical solution 1.5%. Topical NSAIDs provide a therapeutic option for treatment of acute, localized, soft tissue injuries or painful conditions in areas of the body that can be readily treated using the topical route of administration. This article reviews available data on the use of topical NSAID therapy.